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A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects

21. januar 2011 opdateret af: AstraZeneca

A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Act. Twice Daily

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.

Studieoversigt

Status

Afsluttet

Betingelser

Astma

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

134

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Muscle Shoals, Alabama, Forenede Stater
    - Research Site
- Arkansas
  - Little Rock, Arkansas, Forenede Stater
    - Research Site
- California
  - Anaheim, California, Forenede Stater
    - Research Site
  - Los Angeles, California, Forenede Stater
    - Research Site
  - Palmdale, California, Forenede Stater
    - Research Site
  - Rolling Hills Estates, California, Forenede Stater
    - Research Site
- Colorado
  - Denver, Colorado, Forenede Stater
    - Research Site
  - Wheat Ridge, Colorado, Forenede Stater
    - Research Site
- Connecticut
  - Stamford, Connecticut, Forenede Stater
    - Research Site
- Delaware
  - Wilmington, Delaware, Forenede Stater
    - Research Site
- Florida
  - Miami, Florida, Forenede Stater
    - Research Site
- Indiana
  - Avon, Indiana, Forenede Stater
    - Research Site
- Iowa
  - Iowa City, Iowa, Forenede Stater
    - Research Site
- Kansas
  - Shawnee Mission, Kansas, Forenede Stater
    - Research Site
- Louisiana
  - Mandeville, Louisiana, Forenede Stater
    - Research Site
- Maryland
  - Wheaton, Maryland, Forenede Stater
    - Research Site
- Michigan
  - Bay City, Michigan, Forenede Stater
    - Research Site
- Missouri
  - Chesterfield, Missouri, Forenede Stater
    - Research Site
  - Kansas City, Missouri, Forenede Stater
    - Research Site
- Nebraska
  - McCook, Nebraska, Forenede Stater
    - Research Site
  - Scottsbluff, Nebraska, Forenede Stater
    - Research Site
- New Jersey
  - Brick, New Jersey, Forenede Stater
    - Research Site
  - Princeton, New Jersey, Forenede Stater
    - Research Site
- New York
  - North Syracuse, New York, Forenede Stater
    - Research Site
- North Dakota
  - Bismarck, North Dakota, Forenede Stater
    - Research Site
  - Fargo, North Dakota, Forenede Stater
    - Research Site
- Ohio
  - Akron, Ohio, Forenede Stater
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater
    - Research Site
- Oregon
  - Bend, Oregon, Forenede Stater
    - Research Site
  - Lake Oswego, Oregon, Forenede Stater
    - Research Site
- Pennsylvania
  - Bensalem, Pennsylvania, Forenede Stater
    - Research Site
  - Feasterville, Pennsylvania, Forenede Stater
    - Research Site
  - Pittsburgh, Pennsylvania, Forenede Stater
    - Research Site
- Rhode Island
  - East Providence, Rhode Island, Forenede Stater
    - Research Site
- South Carolina
  - Charleston, South Carolina, Forenede Stater
    - Research Site
  - Gaffney, South Carolina, Forenede Stater
    - Research Site
  - Greer, South Carolina, Forenede Stater
    - Research Site
- South Dakota
  - Rapid City, South Dakota, Forenede Stater
    - Research Site
  - Watertown, South Dakota, Forenede Stater
    - Research Site
- Texas
  - Boerne, Texas, Forenede Stater
    - Research Site
  - Dallas, Texas, Forenede Stater
    - Research Site
  - El Paso, Texas, Forenede Stater
    - Research Site
  - San Antonio, Texas, Forenede Stater
    - Research Site
  - Waco, Texas, Forenede Stater
    - Research Site
- Utah
  - Provo, Utah, Forenede Stater
    - Research Site
- Washington
  - Spokane, Washington, Forenede Stater
    - Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Male or Female, > 18 years of age
Mild to moderate asthma requiring treatment with an inhaled corticosteroid
Diagnosis of asthma for at least 6 months

Exclusion Criteria:

Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
Subjects with severe asthma, as judged by investigator
Any significant disease or disorder that may jeopardize a subject's safety

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Tredobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group

Sekundære resultatmål

Resultatmål
To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

Studieleder: Tomas LG Andersson, MD, AstraZenenca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Leidy NK, Gutierrez B, Lampl K, Uryniak T, O'Brien CD. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception. J Asthma. 2009 Dec;46(10):1006-12. doi: 10.3109/02770900903301260.

Hjælpsomme links

Related Info

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2007

Studieafslutning (Faktiske)

1. november 2007

Datoer for studieregistrering

Først indsendt

16. marts 2007

Først indsendt, der opfyldte QC-kriterier